Bicorsan

Bicorsan

procaterol

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Contents
Procaterol HCl.
Description
Each mL contains: Procaterol HCl Hemihydrate equivalent to Procaterol HCl 5 mcg.
Action
Pharmacology: Bronchodilative Activity: The bronchodilation activity of Procaterol HCl Hemihydrate is comparable or more potent than Isoproterenol and more potent than Salbutamol sulfate and Orciprenaline sulfate.
Duration of Bronchodilative Activity: Procaterol HCl Hemihydrate had a longer duration of broncholative action than isoproterenol, trimetoquinol, Orciprenaline sulfate, or Salbutamol sulfate.
Selectivity to β2-adrenergic receptors (Organ selectivity): The selectivity of Procaterol HCl Hemihydrate for β2-adrenergic receptors in the respiratory system was greater than that for such receptors in the cardiovascular system, as compared to Isoproterenol, Trimetoquinol, Orciprenaline sulfate and Salbutamol sulfate.
Anti Allergic Activity: Procaterol HCl Hemihydrate exhibits hypo-allergenic effects by inhibiting increased antibody-induced respiratory resistance, the PCA reaction, and histamine release from sensitized lung tissues in guinea pigs and rats, as well as allergen-induced skin reactions and increases in asthmatic responses to allergen inhalation in bronchial asthma patients, as compared to Isoproterenol, Trimetoquinol, Orciprenaline sulfate, and Salbutamol sulfate. The drug also inhibited allergen-induced, delayed-type, and immediate-type bronchial responses.
Effects on Respiratory Tract System: Procaterol HCl Hemihydrate accelerates ciliary activity in the respiratory tract.
The Inhibitory Effect On The Incidence of Asthma Is Triggered By Exercise: Procaterol HCl Hemihydrate suppresses asthma attacks triggered exercise in patients with bronchial asthma.
Effects on Respiratory Tract Hypersensitivity: Procaterol HCl Hemihydrate inhibits the hypersensitivity of the respiratory tract.
Effects On Increased Vascular Permeability: Procaterol HCl Hemihydrate inhibits the acceleration of vascular permeability and the formation of edema due to various inflammatory agents, with the same potential as Isoproterenol. Procaterol also inhibits lung edema triggered by inhalation of histamine with greater potential than Salbutamol sulfate.
Effect on Cough: Procaterol HCl Hemihydrate inhibits substance-induced cough in upper respiratory tract infections.
Indications/Uses
BICORSAN is indicated for the remission of various symptoms caused by obstructive respiration disorders in the following diseases: bronchial asthma, chronic bronchitis, pulmonary emphysema, acute bronchitis, and asthmatic bronchitis.
Dosage/Direction for Use
The general dose for adult is 10 mL BICORSAN (50 mg Procaterol HCl Hemihydrate) once before bedtime or twice a day (in the morning and before going to bed) via the oral route. The dosage for children aged 6 years and over is 5 mL BICORSAN (25 mg Procaterol HCl Hemihydrate) once before bedtime or twice a day (in the morning and before going to sleep) via the oral route.
The dosage can be adjusted according to the age of the patient and the severity of symptoms. The recommended general dosage for children under 6 years is as follows:
Children under 1 year of age: 2-3 mL BICORSAN (10-15 mg Procaterol HCl Hemihydrate).
Children aged 1-3 years: 3-4 mL BICORSAN (15-20 mg Procaterol HCl Hemihydrate).
Children aged 3-6 years: 4-5 mL BICORSAN (20-25 mg Procaterol HCl Hemihydrate).
Contraindications
Procaterol HCl Hemihydrate is contraindicated in patients with a history of hypersensitivity to the ingredients in this drug.
Special Precautions
Procaterol HCl Hemihydrate syrup should be administered with care in the following patient: Patients with hyperthyroidism; can improve the severity of the disease.
Patients with heart disease; palpitations, arrhythmias, increased disease severity heart, and other symptoms can appear.
For patients with hypertension, an increase in higher blood pressure can occur.
Patients with diabetes mellitus; can improve the severity of the disease. Patients throughout pregnancy or patients suspected of being pregnant.
The main component of long-term bronchial asthma management is anti-inflammatory drugs such as an inhaled corticosteroid. Procaterol HCl Hemihydrate can only be used as adjunctive therapy for patients with symptoms that cannot be controlled with inhaled corticosteroids or other asthma drugs or based on the severity of the disease requiring treatment with Procaterol HCl Hemihydrate. Procaterol HCl Hemihydrate is not a substitute for inhaled corticosteroids and other antiinflammatory drugs; patients, patient supervisors, or other legally authorized persons should be advised not to reduce the dose of inhaled corticosteroids or to stop using inhaled corticosteroids and switch to monotherapy with Procaterol HCl Hemihydrate unless specifically recommended by doctors, even if the patient feels improvement in symptoms by using Procaterol HCl Hemihydrate.
Throughout the long-term management of bronchial asthma with Procaterol HCl Hemihydrate, patients can experience episodes of acute asthma. Patients, or patient supervisors, or other legally authorized persons should be instructed to use other drugs that are adequate in addition to Procaterol HCl Hemihydrate, such as inhaled stimulant β2 short-acting drugs if acute asthma episodes occur during treatment with Procaterol HCl Hemihydrate. Additionally when the use of these drugs becomes increasingly often or the expected therapeutic effect is not observed with the initial dose of treatment, the patient's asthma may not be controlled enough. The patient, the patient's supervisor, or other people who are legally authorized should be instructed to consult a doctor immediately and receive adequate medication in this case. In addition, in conditions that can be life-threatening, anti-inflammatory treatment needs to be given at an adequate dose, such by increasing the dose of inhaled corticosteroids.
If the desired therapeutic effect of Procaterol HCl Hemihydrate Syrup cannot be achieved at the recommended dose, the drug should be discontinued.
The provision of Procaterol HCl Hemihydrate continuously in excessive amounts can cause cardiac arrhythmia and cardiac arrest. Special attention must be given to avoid giving drugs more than the recommended dose.
Appropriate dosage or other measures must be considered when prescribing Procaterol HCl Hemihydrate to elderly patients because elderly patients can be physiologically more sensitive to this drug than younger patients.
This drug can only be given to pregnant women or women who are suspected of being pregnant if the expected therapeutic benefits outweigh any possible risks. The safety of using this drug during pregnancy is unknown.
The breastfeeding process must be paused before starting treatment with Procaterol HCl Hemihydrate because Procaterol HCl Hemihydrate is also excreted through breast milk.
The safety of this drug in babies born with low weight and neonates is unknown. There is no clinical experience in babies born with low weight and neonates.
These drugs tend to be able to inhibit skin reactions in allergen testing. Procaterol HCl Hemihydrate administration must be stopped 12 hours before the test.
Damage to heart muscle tissue was observed in studies test animals; however, the damage has also been reported with the use of other β2-adrenergic agonists.
Mesovarian leiomyoma has been observed in long term toxicity studies in test animals; however, these tumors are species-specific tumors and tend to form on long-term β2-adrenergic agonists.
Patients should be instructed to keep the drug out of the reach of children to prevent accidental ingestion.
Adverse Reactions
Clinically significant undesirable reactions: Shock anaphylactoid reaction: Anaphylactoid shock or reactions can occur, so patients must be monitored closely. If there are abnormal findings, then the drug administration must be stopped and appropriate medical treatment given.
Significant decrease in serum potassium levels: Significant decreases in serum potassium levels have been reported in patients receiving Procaterol HCl Hemihydrate. If xanthine derivatives, corticosteroids or diuretics are given with this drug in patients with decreased serum potassium levels triggered due to β2-adrenergic agonists. Serum potassium levels must be monitored closely in hypoxic patients because of the possibility of worsening cardiac arrhythmias due to decreased serum potassium levels. See table.


Click on icon to see table/diagram/image


If symptoms of hypersensitivity occur, stop administering the drug.
Drug Interactions
Procaterol HCl Hemihydrate must be given with caution if given along with the following medicines.
Joint use of Procaterol HCl Hemihydrate with catecholamine class drugs (eg Epinephrine and Isoproterenol) can cause arrhythmias or, in some cases, cardiac arrest. Epinephrine, Isoproterenol, and other catecholamine groups potentiate the action of adrenoreceptor stimulation of this drug, which may trigger arrhythmias.
Joint use of Procaterol HCl Hemihydrate with Xanthine derivatives (eg. Theophylline, Aminophylline hydrate, and Dipropylline) can worsen hypokalemia and undesirable cardiovascular reactions (e.g. tachycardia and arrhythmias) due to β-adrenergic stimulation. Xanthine derivatives potentiate the action of the adrenoreceptor stimulation of Procaterol, which can result in decreased serum potassium levels and exacerbate unwanted cardiovascular reactions. The mechanism of the cause of hypokalemia induction is unknown. If any abnormalities are found, the dose must be reduced or the use of the drug stopped immediately.
Joint use of Procaterol HCl Hemihydrate with corticosteroids (e.g. Betamethasone, Prednisolone, and Hydrocortisone sodium succinate) or diuretics (e.g. Furosemide) can cause a decrease in serum potassium levels which triggers arrhythmias. Corticosteroids and diuretics increase potassium excretion from the kidney tubules, which may cause a decrease in excess serum potassium levels. If any abnormalities are found, the dose must be reduced or the use of the drug stopped immediately.
Storage
Store below 30°C, protected from light.
Use within 3 months after opening.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03CC08 - procaterol ; Belongs to the class of adrenergics for systemic use, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.
Presentation/Packing
Form
Bicorsan syr 5 mcg/mL
Packing/Price
60 mL x 1's (Rp48,200/boks)
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